(87 days)
Genex® is indicated only for bony voids or defects/gaps that are not intrinsic to the stability of the bony structure.
Genex® is indicated to be gently packed into voids or defects of the skeletal system (ie long bones, extemities, spine and pelvis).
Genex® bone graft substitute resultant paste can be injected, digitally packed into the bone void to cure in situ or moulded into solid implants that are to be gently packed into the defect
The bony defects or cavaties may be surgically created or the result of traumatic injury. Genex® provides a bone graft substitute that resorbs and is replaced with bone during the healing process.
Genex® is a calcium salt bone graft substitute and is provided sterile for single patient use. When Genex® is placed in the defect; bone grows in apposition to the implant, filling the pores with new bone during the healing process.
Genex® is completely resorbed and replaced with bone during the healing process.
Genex® is provided sterile for single use only
The provided text does not contain information about acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML medical device. The document is a 510(k) summary for a bone void filler called Genex®, dating from 2008.
The document discusses:
- Device Description: Genex® as a calcium salt bone graft substitute.
- Intended Use/Indications: For bony voids or defects not intrinsic to stability, to be packed/injected into the skeletal system.
- Summary of Technology & Non-Clinical Testing: States that Genex® has the same technological characteristics as the predicate device and is substantially equivalent. It notes that "Data supplied demonstrates that Genex® is substantially equivalent to the predicate device and any differences do not any concerns regarding safety and effectiveness." This implies non-clinical testing was done, but the details of the specific tests, their methodologies, and acceptance criteria are not provided.
- Substantial Equivalence: Asserts that indications, contraindications, risks, and potential adverse events are the same as the predicate device.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document is focused on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for medical devices that does not typically involve the kind of performance studies with specific acceptance criteria and ground truth validation that you've described for AI/ML devices.
To answer your questions accurately, I would need a document that describes the development and validation of an AI/ML medical device, including performance metrics, test sets, ground truth establishment, and study designs.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.